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Multimodal intensive prehabilitation in high impact surgery to reduce postoperative complications

Multimodal intensive prehabilitation in high impact surgery: a stepped-wedge cluster randomized trial, from a patient’s and hospital-efficiency perspective

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28368
Enrollment
2830
Registered
2020-06-05
Start date
2021-03-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colon cancer, rectal cancer, esophageal cancer, liver metastases from colorectal cancer, pancreato-biliary cancer, peritoneal carcinomatosis from colorectal cancer, retroperitoneal sarcoma, abdominal aortic aneurysm, renal cancer, bladder cancer, supratentorial meningioma, hip arthrosis, knee or hip arthroplasty failure, osteosarcoma, pulmonary cancer, thoracic aortic aneurysm, head and neck cancer, mouth cancer, breast reconstruction, ovarian cancer, endometrial cancer, vulvar cancer

Interventions

Patients will undergo a multimodal intensive prehabilitation program prior to high impact surgery including an exercise program, a nutritional intervention, psychological support and smoking cessation

Sponsors

Radboudumc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: o Adult patients (>16 years), o scheduled for elective high impact surgery, o independent of (neo-) chemotherapy and/or radiotherapy, o obtained written informed consent.

Exclusion criteria

Exclusion criteria: o Paralytic or immobilized patients who are not able to complete exercise intervention, o premorbid conditions or orthopedic impairments which contraindicate exercise, o inability to undergo the intervention due to lack of understanding or instructability (e.g. cognitive disability or illiteracy (disability to read and understand Dutch)). o unstable cardiac or respiratory disease which contraindicate exercise, o renal failure stage 3 or higher which contraindicate protein supplementation o ASA score 4 or higher,

Design outcomes

Primary

MeasureTime frame
To determine the effects of a multimodal intensive prehabilitation program a high-risk patient group on complications (Clavien-Dindo score and Comprehensive Complication Index (CCI) score)

Secondary

MeasureTime frame
To investigate the effects of multimodal intensive personalized prehabilitation on an: - Individual patient’s level, i.e. length of hospital stay (in days), physical fitness (estimated VO2 peak, indirect 1 repetition measures, physical activity), nutritional status (body weight, fat-free mass), mental health (HRQoL), intervention adherence - Mechanistic level, i.e. innate immune response (degree of immunoparalysis) - Hospital-efficiency level: costs due to complications, costs due to length of hospital stay, budget impact, cost-effectiveness - Macro-economic level: changes in patients volumes, shifts in care between 2nd and 1st line healthcare

Contacts

Public ContactDieuwke Strijker

Radboudumc

dieuwke.strijker@radboudumc.nl+31628239648

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)